A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 660 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.
This is a prospective, observer blind, multi-site, randomized, controlled, equivalence trial. The general anesthesia group will receive sevoflurane (intervention drug) for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg per kg) administered via caudal or ilioinguinal nerve block. The airway can be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents.
The regional group will have no sedative agent. The regional blockade may be with spinal alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. The maximum dose of 2.5 mg per kg of bupivacaine can be used.
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Regional Anesthesia, General Anesthesia
The Children's Hospital Denver
Children's Hospital Boston
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00756600
- Information obtained from ClinicalTrials.gov on August 16, 2012
Medical and Biotech [MESH] Definitions
Delayed Emergence From Anesthesia
Abnormally slow pace of regaining CONSCIOUSNESS after general anesthesia (ANESTHESIA, GENERAL) usually given during surgical procedures. This condition is characterized by persistent somnolence.
An abdominal hernia with an external bulge in the GROIN region. It can be classified by the location of herniation. Indirect inguinal hernias occur through the internal inguinal ring. Direct inguinal hernias occur through defects in the ABDOMINAL WALL (transversalis fascia) in Hesselbach's triangle. The former type is commonly seen in children and young adults; the latter in adults.
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Anesthesia Recovery Period
The period of emergence from general anesthesia, where different elements of consciousness return at different rates.
A barbiturate that is administered intravenously for the production of complete anesthesia of short duration, for the induction of general anesthesia, or for inducing a hypnotic state. (From Martindale, The Extra Pharmacopoeia, 30th ed, p919)
The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal...
This study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general an...
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an total...
This is a quality assurance database to prospectively examine regional anesthesia outcomes at Toronto Western Hospital.
The purpose of the study is 1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under...
Neonates with inguinal hernia face a relatively high risk of incarcerated hernia and bowel obstruction and this therefore requires surgical treatment. Complications following general anesthesia even f...
BACKGROUND: Persistent pain is common after inguinal hernia repair. The methods of surgery and anesthesia influence the risk. Local anesthesia and laparoscopic procedures reduce the risk for postopera...
Modern anesthesia is handling an increasing number of patients with neurological diseases who require narcosis. Regional anesthesia techniques offer qualities which might be advantageous for this grou...
Management of patients undergoing dialysis after inguinal hernia surgery has not been standardized. This report presents the results of 9 patients with inguinal hernias (11 hernias) who were undergoin...
Comparison of anesthesia technique on outcomes of endovascular repair of abdominal aortic aneurysms: a five-year review of monitored anesthesia care with local anesthesia vs. general or regional anesthesia.
AIM: This retrospective study compares outcomes according to anesthesia technique of a consecutive series of 48 endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) performed by on...